Tirofiban Plus Intravenous Thrombolysis in Acute Anterior Choroidal Infarction or Paramedian Pontine Infarction

NCT ID: NCT05733507

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2023-09-13

Brief Summary

TITACIPPI (Tirofiban with Intravenous Thrombolysis in Acute Anterior Choroidal Infarction [ACI] and Paramedian Pontine Infarction [IPP]) study aimed to evaluate the efficacy and safety of simultaneous infusion of tirofiban with intravenous thrombolysis (IVT + tirofiban group) compared to IVT alone (IVT alone group) in patients with ACI or PPI. TITACIPPI study is a retrospective, single-center observational study conducted from March 01, 2014, to December 31, 2022.

Detailed Description

ACI and PPI are frequently associated with clinical fluctuations, characterized by recurrent transient more or less regressive stereotyped episodes of focal motor deficits affecting the face, arm, and leg, and finally with a risk of lasting neurological worsening that can lead to definite residual neurological disability. These ischemic strokes (ACI and PPI) are not very sensitive to IVT, thus 26% to 48% will experience neurological aggravation despite the administration of this treatment. Studies in Asia have shown a possible clinical benefit of simultaneous infusion of tirofiban with IVT in patients with ischemic stroke of atheromatous or microatheromatous origin without additional bleeding risk. To date, no studies have tested the efficacy of simultaneous infusion of tirofiban and IVT in the well-defined subgroup of ACI and PPI and a non-Asian population.

Conditions

Acute Anterior Choroidal Infarction (ACI); Paramedian Pontine Infarction (IPP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Intravenous thrombolysis (IVT)

group of patients treated with IVT alone

IVT with tenecteplase or alteplase

Intervention Type: PROCEDURE

Patients received intravenous tenecteplase 0.25mg/kg (maximum dose: 25mg), administered as a bolus over 5 to 10 seconds or intravenous alteplase 0.9 mg/kg (maximum dose: 90mg), 10% as bolus and the remainder as continuous perfusion over 1 hour.

Tirofiban + IVT

groups of patients treated with simultaneous infusion of tirofiban and IVT

Intervention Name : Tirofiban and IVT with tenecteplase or alteplase

Intervention Type: PROCEDURE

IVT with tenecteplase or alteplase with continuous infusion of tirofiban 0.4µg/kg/min continued for 24 to 48 hours.

Interventions

IVT with tenecteplase or alteplase

Patients received intravenous tenecteplase 0.25mg/kg (maximum dose: 25mg), administered as a bolus over 5 to 10 seconds or intravenous alteplase 0.9 mg/kg (maximum dose: 90mg), 10% as bolus and the remainder as continuous perfusion over 1 hour.

Intervention Type: PROCEDURE

Intervention Name : Tirofiban and IVT with tenecteplase or alteplase

IVT with tenecteplase or alteplase with continuous infusion of tirofiban 0.4µg/kg/min continued for 24 to 48 hours.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥ 18 years with ACI or PPI between March 01, 2014 and December 31, 2022.
• Patients hospitalized in the stroke unit of Centre Hospitalier Sud Francilien in the acute phase of their ischemic stroke (FLAIR negative on the pre-treatment brain MRI allowing IVT).
• Patients with NIHSS ≥ 2 on admission
• Patients treated with IVT
• For the experimental group: patients treated with tirofiban at 0.4 μg/kg/min with the start of infusion within 1 hour of IVT initiation.
• Patients with post-treatment brain MRI within 24-36h.

Exclusion Criteria

• Patients with contraindications to IVT (cardiac, thoracic or digestive surgery less than 14 days old, thrombocytopenia < 100,000/mm3, etc.).
• Absence of MRI as initial imaging.
• Less than 24 hours of continuous infusion of tirofiban.
• Patients at high risk of cerebral hemorrhage: severe microangiopathy (Fazekas Score 3), microbleeds > 5, or leptomeningeal hemosiderosis suggestive of amyloid angiopathy.
• Patients with pre-stroke mRS ≥ 3.
• Patients informed of the research and objecting to the collection of their data.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Countries

France

Other Identifiers

2022/0039

Identifier Type: -

Identifier Source: org_study_id